Clinical Evaluation Comprehensive data analysis and medical writing expertise

Market-leading Clinical Evaluation and CER-writing service delivered by highly-skilled medical professionals.

Bringing medical expertise to Clinical Evaluation

MDR Clinical Evaluation requires a detailed analysis of safety and performance data from multiple sources. It must be performed for all medical devices and summarised in a Clinical Evaluation Report (CER).

Our team of MDR-trained medical professionals are experts at applying their clinical knowledge and data analysis capabilities to MDR Clinical Evaluation.

  • Data analysis & literature searching

    Meet MDR requirements for Clinical Evaluation through objective and comprehensive data analysis, assimilation and interpretation.

  • CER-writing service

    The medical writing capabilities of medical professionals brought directly to your CER.

  • Efficient and cost-effective

    All the benefits of engaging highly-trained clinical data specialists without the costs and inconvenience of workforce expansion.

Our Clinical Evaluation process

Mantra Systems' Clinical Evaluation process

Our Clinical Evaluation process begins with a free consultation to discuss your requirements.

Comprehensive analysis of internal and external data against MDR standards enables production of professional CERs written by our medical experts.

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Medical device Clinical Evaluation ready for the MDR

Clinical Evaluation involves a detailed analysis of clinical data to assess compliance with relevant MDR Annex I GSPRs and the benefit-risk profile of the device.

Our highly-skilled team will analyse and interpret your clinical data in order to satisfy the rigourous standards for Clinical Evaluation under the MDR.

  • Direct access to medical professionals

    Get detailed insights from our highly-trained professionals throughout the clinical evaluation process.

  • 360° Clinical Evaluation

    We handle the entire process from start-to-finish and produce market-leading CERs.

  • Adherence to all relevant standards

    Clinical Evaluation in accordance with MDR Annex XIV and MEDDEV 2.7/1 rev 4.

Call us now to discuss your MDR requirements:

(+44) 0114 386 3349

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MDR Consulting

Our team of medical doctors are specialists at building the clinical evidence portfolio that you need for MDR compliance of your products.

Download our free Mastering the MDR White Paper — An easily digestible summary of the EU MDR

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MDR Training

Our comprehensive training services are delivered by experts and address all aspects of MDR compliance.

MDR Guidance

Our unique MDR guidance resources are written by our medical experts and free to use. They cover all aspects of the new Medical Device Regulation.

Do you have any questions about our MDR services?

Contact us